The purpose of this study is to test the efficacy of a clinic-based intervention designed to reduce illness uncertainty for parents of children who have been recently diagnosed with cancer.
The proposed trial will test the efficacy of the parent-focused clinic-based Parent Uncertainty Management Intervention (PUMI) to improve the outcomes of children newly diagnosed with cancer and their parents. Participants will be randomly assigned to receive equivalent doses of either the PUMI or an Education/Support (ESO) group. Theoretically driven by Mishel's model of illness uncertainty, the PUMI will teach parents about uncertainty prevention and management through the use of medically-specific communication, information management, and problem-solving skills via in-clinic sessions and an online portal. Parents and children will complete measures online at baseline, 1-week, and 3-, 6-, and 12-month follow-ups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
279
• The intervention is 6 sessions lasting approximately 45 minutes reviewing ways to help prevent and respond to illness uncertainty. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist.
This control is 6 sessions lasting approximately 45 minutes providing education on cancer etiology, medical treatments, side effects, potential short- and long-term effects of treatment and resources that are often helpful to parents of children with cancer. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Psychosocial Functioning as assessed by the global severity index (GSI) of the symptom checklist 90.
indicator of global psychological symptoms
Time frame: Change in (global severity index) GSI score from baseline to 1-week post-intervention
Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90.
indicator of global psychological symptoms
Time frame: Change in GSI score from baseline to 3-month post-intervention
Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90.
indicator of global psychological symptoms
Time frame: Change in GSI score from baseline to 6-month post-intervention
Psychosocial Functioning as assessed by the global severity index of the symptom checklist 90.
indicator of global psychological symptoms
Time frame: Change in GSI score from baseline to 12-month post-intervention
Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)
Measure of caregiver post-traumatic stress symptoms
Time frame: Change in IES-R total score score from baseline to 1-week post-intervention
Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)
Measure of caregiver post-traumatic stress symptoms
Time frame: Change in IES-R total score score from baseline to 3-month post-intervention
Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)
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Measure of caregiver post-traumatic stress symptoms
Time frame: Change in IES-R total score score from baseline to 6-month post-intervention
Post-Traumatic Stress Symptoms as assessed by the Impact of Events Scale-Revised (IES-R)
Measure of caregiver post-traumatic stress symptoms
Time frame: Change in IES-R total score score from baseline to 12-month post-intervention